ModerateClass IITerminated

FDA Devices recall · Reported December 8, 2021

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0318-2022.

Q: Where was the recalled product distributed?

Distribution: U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0318-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

Recall #: Z-0318-2022
Affected scope: 137,200 devices
Initiated: November 2, 2021

Compiled from official public sources by the editorial team. · Updated July 2026

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Magnolia Medical Technologies, Inc. recalled The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Ster… - a moderate-severity action.

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Ster… was recalled by Magnolia Medical Technologies, Inc. in December 8, 2021. Reason: Due to an uptick of complaints associated with premature needle retraction of blood collection system.. Check the official notice for the remedy. Verify recall #Z-0318-2022 with the FDA Devices before acting.

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The recall

Magnolia Medical Technologies, Inc. issued this moderate-severity FDA Devices recall-Due to an uptick of complaints associated with premature needle retraction of blood collection system..

Moderate
severity level: 137K units
affected scope: Class II
classification: December 8, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0318-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0318-2022) was formally reported on December 8, 2021, with the manufacturer initiating the action on November 2, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Magnolia Medical Technologies, Inc. is listed as the recalling firm, operating out of Seattle, WA. Federal records list the affected scope as 137,200 devices, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Due to an uptick of complaints associated with premature needle retraction of blood collection system. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

137,200 devices

Related Recalls

3 from same agency

Product description

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

Reason for recall

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0318-2022
Date reported	December 8, 2021
Date initiated	November 2, 2021
Recalling firm	Magnolia Medical Technologies, Inc.
Firm location	Seattle, WA
Affected scope	137,200 devices
Distribution	U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

137,200 devices units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0318-2022) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0318-2022.

Where was the recalled product distributed? ▼

Distribution: U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0318-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 8, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.